Study to Evaluate Safety, Tolerability and Efficacy of Oral E-B-FAHF-2 in Mild-to-Moderate Crohn's Disease
Age: 18 - 30 years
Healthy Subjects: No
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: February 01, 2022
End Date: April 01, 2023
Inclusion Criteria: Participants must fulfill all of the following criteria to be eligible for inclusion in the study:
- Male and female subjects with Crohn's disease (CD), 18-30 years of age and otherwise in good health as determined by medical history and physical examination
- Subjects weighing 25kg or more
- History of recently diagnosed (within 12 months) ileal or ileal-colonic CD that is mild-to-moderate in severity as determined by standard history, physical, endoscopy scoring results, CD Activity Index (CDAI); patients with severe disease, which can be rapidly progressive and result in gastrointestinal hemorrhage, intestinal fistulas, abscesses and other complications, will be excluded because their risk of requiring rescue medications including steroids and biologicals as well as hospitalization or surgery are high.
- The subject is able to swallow the required capsules and tablets.
- The subject has been immunized according to the guidelines set forth by the CDC.
- The subject agrees to participate in the study.
- Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
- Evidence of inflammation on colonoscopy with an SES-CD >3.
- Either an elevated fecal calprotectin or an elevated CRP.
- Willing and able to undergo upper endoscopy and colonoscopy with disease flares and after 6 months of treatment for the assessment of disease as per the standard of care for CD.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria: Subjects will be excluded from the study if any of the following apply:
- Patients with severe disease as determined by CDAI, or SES-CD scores at initial endoscopy of greater than 16, or strictures or large ulcerations on endoscopy that exemplify severe disease.
- Acute febrile illness within 1 week before administration of study therapeutic formula.
- Any history of other systemic diseases that, in the investigator's opinion, would preclude the subject from participating in this study, e.g. other autoimmune disease, neoplasm, HIV or hepatitis infection.
- Abnormal hepatic function (ALT, AST or bilirubin >2 x upper limit of normal).
- Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3).
- Abnormal renal function (BUN and creatinine >1.5 x upper limit of normal for age or abnormal eGFR for age and race).
- Clinically significant abnormal electrocardiogram.
- Participation in another experimental therapy study within 30 days of this study.
- History of alcohol or drug abuse.
- Pregnant or lactating female subjects: females of childbearing potential will need a negative pregnancy test at screening and at each visit to be considered and continued in this study. Lactating females will be excluded from the study.
- Use of intravenous or oral systemic steroids within the past six months or any use of immunomodulators or biologic medications, since these drugs have lasting effects and alter the subject's cytokine profile thus affecting the results of the study.
- Active perirectal disease including fistuli or abcesses.
- Use of any other CAM products.
- Known allergy to FAHF-2/B-FAHF-2 or any of its components.
- Concurrent use of any medications known to alter CYP3A function.
- Any other medical concerns not listed above that in the invistigator's opinion may pose additional risks, interfere with adherence, or impact the quality or interpretation of the data.
- Crohn Disease